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Fritz Stephan: Compliance in an Exceptionally Highly Regulated Environment

Fritz Stephan Medical Case StudyThe increasingly rigorous requirements of safety-critical regulations pose a challenge to companies developing products for the automotive, medical device, railway, nuclear, financial, pharmaceutical etc. industries worldwide.

Achieving compliance with a single standard can be difficult enough. But in the case of special products such as Fritz Stephan's mobile emergency care units, several standards of multiple industries apply to a single product.

How does a high-tech company achieve compliance with avionics and medical device regulatory standards at the same time? Our new case study explains how this German medical device innovator was able to build mature custom processes to support compliance using codeBeamer ALM.

Limited traceability in a legacy tool environment

Prior to implementing codeBeamer ALM, the development team at Fritz Stephan GmbH, like many other developers of medical technology, was relying on a mix of single-point software tools. Requirements were stored and managed using Microsoft Word and Excel documents stored on local computers, making version control a nightmare.

If you have ever tried using such inadequate tools in a collaborative environment, you know that it requires immense effort to make sure that all stakeholders always have access to up-to-date information.

What's more, as documents are being shuffled across teams on a daily basis while other documents are being generated for development tasks, testing purposes, etc. things are bound to get confusing. Traceability is very difficult to achieve in such a fragmented development environment, rendering audit preparations very time-consuming.

Fritz Stephan's developers realized early on that with such specialized compliance requirements (where a single product had to comply with certain medical and avionics regulations at the same time), error-prone manual processes wouldn't work out in the long run.

Related reading:

Medtronic Case Study: How Does the World's Largest Medical Technology Company Use codeBeamer ALM?

DATATRAK Case Study: A Success Story of Traceability and Process Transparency

So Fritz Stephan GmbH launched a tool research & evaluation process to see how they could modernize their processes using a mature integrated ALM tool.

From MS Word & Excel to next generation ALM

After a thorough evaluation of ALM products on the market, Fritz Stephan deployed codeBeamer ALM in their software development department, and soon started using the tool for various other processes. With information flowing freely across teams, departments and processes, Fritz Stephan was able to ensure a consistent chain of product information throughout the lifecycle. Auditors were astonished to see how simply Fritz Stephan developers were able to pull reports at compliance audits: the team is in a state of continuous compliance, and reports are easily accessible at all times.

Having optimized their processes using codeBeamer ALM, this German medical device developer realizes great savings of time and effort throughout the lifecycle. Collaboration is smooth, traceability is automatically ensured, and the costs of development and compliance have been greatly reduced.

Those are just some of the benefits the company was able to achieve with codeBeamer ALM. To learn more about how Fritz Stephan ensures compliance while reducing costs, download our free case study below, or get in touch with us. Looking for the same benefits? Start your free trial of codeBeamer ALM right away!

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Medical Case Study: Fritz Stephan

Medical Case Study: Fritz Stephan